The list of new standards, current draft standards and projects is a selection that might be relevant for our clients. It therefore does not claim to be complete. The compilation has been made very carefully and serves as an overview for you. However, errors cannot be excluded, and we cannot assume any liability. The selection draws information from the following standards committees:
DIN EN 12183 (standard)
Muscle-powered wheelchairs
Requirements and test methods; German version EN 12183:2022
Date: 2022-12
DIN EN 12184 (standard)
Electric wheelchairs, scooters and associated chargers
Requirements and test methods; German version EN 12184:2022
Date: 2022-12
DIN EN ISO 21856 (standard)
Assistive products
General requirements and test methods (ISO 21856:2022); German version EN ISO 21856:2022
Date: 2022-12
DIN EN ISO 8362-2 (Standard)
Injection containers and accessories
Part 2: Stoppers for injection vials (ISO 8362-2:2015 + Amd 1:2022); German version EN ISO 8362-2:2015 + A1:2022
Date: 2022-12
DIN EN ISO 8536-3 (standard)
Infusion equipment for medical use
Part 3: Aluminium crimp caps for infusion bottles (ISO 8536-3:2009 + Amd 1:2022); German version EN ISO 8536-3:2009 + A1:2022
Date: 2022-12
IEC 60601-2-83:2019+AMD1:2022 (standard)
Medical Electrical Equipment
Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment
Date: 2022-12
ISO 81060-3:2022 (standard)
Non-invasive Sphygmomanometers
Part 3: Clinical investigation of continuous non-invasive automated measurement type
Date: 2022-12
DIN EN ISO 18562-1 (Draft)
Biocompatibility evaluation of breathing gas pathways in healthcare applications
Part 1: Assessment and verification within a risk management process (ISO/DIS 18562-1:2022); German and English version prEN ISO 18562-1:2022
Date: 2022-12
DIN EN ISO 18562-2 (Draft)
Biocompatibility evaluation of breathing gas pathways in healthcare applications
Part 2: Tests for emissions of particulate matter (ISO/DIS 18562-2:2022); German and English version prEN ISO 18562-2:2022
Date: 2022-12
DIN EN ISO 18562-3 (Draft)
Biocompatibility evaluation of breathing gas pathways in healthcare applications
Part 3: Tests for emissions of volatile organic compounds (VOCs) (ISO/DIS 18562-3:2022); German and English version prEN ISO 18562-3:2022
Date: 2022-12
DIN EN ISO 18562-4 (Draft)
Biocompatibility evaluation of breathing gas pathways in healthcare applications
Part 4: Tests for leachables in condensates (ISO/DIS 18562-4:2022); German and English version prEN ISO 18562-4:2022
Date: 2022-12
DIN EN ISO 10555-1 (Draft)
Intravascular catheters - Sterile catheters for single use
Part 1: General requirements (ISO/DIS 10555-1:2022); German and English version prEN ISO 10555-1:2022
Date: 2022-12
DIN EN ISO 10555-4
Intravascular catheters - Sterile catheters for single use
Part 4: Balloon dilatation catheters (ISO/DIS 10555-4:2022); German and English version prEN ISO 10555-4:2022
Date: 2022-12
ISO/AWI 14155 (Project)
Clinical testing of medical devices on humans
Good clinical practice
Date: 2022-12-12
DIN EN ISO 11979-1 (Project)
Ophthalmic implants - Intraocular lenses
Part 1: Vocabulary
Date: 2022-12-11
DIN EN ISO 11979-4 (Project)
Ophthalmic implants - Intraocular lenses
Part 4: Labelling and information
Date: 2022-12-11
ISO/AWI 18967-1 (Project)
Implants for surgery – Bone anchoring systems
Part 1: Part 1: Impact, expandable and threaded suture anchors requirements
Date: 2022-12-08
DIN EN ISO 15883-6 (Project)
Washer-disinfectors
Part 6: Requirements and test methods for washer-disinfectors with thermal disinfection for non-critical medical devices and accessories in the healthcare sector
Date: 2022-12-21
ISO/AWI TS 5137 (Project)
Medical device maintenance management for healthcare delivery organizations
Date: 2022-12-19
ISO 15223-1 AMD 1 (Project)
Medical devices - Symbols for use in the context of the information to be provided by the manufacturer
Part 1: General requirements - Modification 1
Date: 2022-12-19
DIN EN ISO 18250-3 (Project)
Medical devices - Connectors for delivery systems for healthcare applications
Part 3: Enteral applications
Date: 2022-12-09
DIN EN ISO 18250-1 (Project)
Medical devices - Connectors for delivery systems for healthcare applications
Part 1: General requirements and general test methods
Date: 2022-12-09
DIN EN ISO 18250-6 (Project)
Connectors for dispensing systems for healthcare applications
Part 6: Neuraxial applications
Date: 2022-12-09
DIN EN ISO 18250-7
Connectors for dispensing systems for healthcare applications
Part 7: Connectors for intravascular infusion
Date: 2022-12-09
DIN EN ISO 18250-8 (Project)
Medical devices - Connectors for delivery systems for healthcare applications
Part 8: Citrate-based anticoagulant solution for apheresis applications
Date: 2022-12-09
ISO/AWI 15883-6 (Project)
Washer-disinfectors
Part 6: Requirements and test methods for washer-disinfectors with thermal disinfection for non-critical medical devices and accessories in the healthcare sector
Date: 2022-12-09
Read more about:
- New standards and standards projects from November 2022
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